Bioequivalence and Bioavailability Forum

Dear ssk,

frequency of vitals check-up depends on medicine for which we are conducting ba/be study.

Generally vitals are checked around Tmax as chances of adverse events are more at that time.

If both medcine and its metabolite are showing pharmacological activity, then we need to check vitals around (i.e. before and after) Tmax of medicine and its metabolite.

If medicine is used in an extended release formulation, then we need to check vitals over a period of time till it reaches maximum concentration and during its elimination phase.

If it get stored in any organ and / bind to plasma protein then its vital check up time depend on its elimination pattern.

Apart from that vitals are checked duing checkin to ensure that we are taking healthy subjects, before dosing to ensure that subjects were adjusted to new envoronment and did not develop significant illness during the stay, during checkout to ensure that subjects did not develop advere event after dosing and they are as healthy as they were before check-in.

If subjects need to visit study center for giving blood sample i.e. ambulatory sample, at that time we need to check their vitals.

If subjects need to stay for 2-4 days in study center, vitals need to checked during morning and evening.

Regards,
Sumanta.